Cyclophosphamide and Busulfan as Conditioning Regimen Before Allogeneic HSCT

University Hospital Basel

Status

Completed

Conditions

Precursor Myeloid Neoplasms

Lymphoid Neoplasms

Myeloid Leukemia

Treatments

Drug: Busulfan-Cyclophosphamide as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell Transplantation

Drug: Cyclophosphamide-Busulfan as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell Transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT01779882

BuCyBu study

Details and patient eligibility

About

The aim of this study is to test the hypothesis, that the order of application of Busulfan (BU) and Cyclophosphamide (CY) has an impact on toxicity after allogeneic Hematopoietic stem cell transplantation (HSCT) and that CY-BU reduces liver toxicity compared to BU-CY.

Enrollment

72 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients planned to undergo an allogeneic HSCT with myeloablative conditioning
Age 18 - 65 years
Myeloid leukemia respectively related precursor neoplasms (acute myeloid leukemia, chronic myeloid leukemia, myelodysplastic syndrome), or lymphoid neoplasms (acute lymphoblastic leukemia/lymphoma, mature B-/T-/natural killer (NK)-cell neoplasms).
Human Leukocyte Antigen (HLA)-identical sibling donor or matched unrelated (min. 10/10 Ag matched)
Patients with a history of hepatitis might be included, if no contraindication for HSCT exists.
Patient must give written informed consent

Exclusion criteria

Indication other than myeloid leukemia respectively related precursor neoplasms, or lymphoid neoplasms.
Severe liver damage for > 2 weeks (bilirubin > 3xupper limit normal (ULN) or ASAT/ALAT > 5xULN)
HIV infection
Donor other than HLA-identical sibling or min. 10/10 matched unrelated donor
Pregnant or lactating women
Lack of written informed consent